18 and older, any sex, with Leukoplakia, Oral. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response Rate (BORR)Primary· Participants were followed up to 164 days.
BORR on treatment is the percentage of participants who achieved CR or PR. Best overall response is the best response recorded from study registration until the first disease progression/diagnosis of invasive OSCC (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Best overall response was determined by using composite scores based on both measurement and histology, matching to the response grid as following, (1)CR, a decrease of \>80% or more; (2)PR, a decrease of 40-80%; (3)SD, neither PR or PD, (4)PD, an increase of 10% or more.
Group
Value
95% CI
Nivolumab
36.4
20.4 – 54.9
COMD QLQ Score Change From Baseline to End of TreatmentSecondary· Assessed at baseline and end of treatment. Treatment duration in days was a median (range) of 105 (21-164).
Quality of Life was evaluated using COMD QLQ (chronic oral mucosal diseases quality of life questionnaire). The range of the possible total score is 0-104, and low score is a good QoL.
Group
Value
95% CI
Nivolumab
-3
-36 – 14
Grade 1/2 Toxicity RateSecondary· Participants were followed up to 194 days.
The proportion of participants who experienced a maximum grade 1 or 2 adverse events regardless of treatment attribution based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Group
Value
95% CI
Nivolumab
0.75
0.58 – 0.89
Grade 3/4 Toxicity RateSecondary· Participants were followed up to 194 days.
The proportion of participants who experienced a maximum grade 3 or 4 adverse events regardless of treatment attribution based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Group
Value
95% CI
Nivolumab
0.21
0.09 – 0.39
Time to the Next Surgery for a Head and Neck MalignancySecondary· Participants were followed up to 13.3 months.
Time to Next Surgery is defined as time from the first study treatment to any head \& neck surgery or resection for biopsy-proven carcinoma in situ (CIS) or invasive oral carcinoma.
Group
Value
95% CI
Nivolumab
6.5
2.0 – 13.3
Cancer Free Survival at 2 Years (CFS2)Secondary· Participants were followed up to 2 years.
CFS2 is the probability of participants remaining alive and cancer-free at 2 years based on Kaplan-Meier methodology. Cancer-Free Survival (CFS) is defined as the time from study registration to development of invasive oral cancer or death due to any cause. Participants alive without disease progression or recurrence (of invasive oral cancer) are censored at date of last disease evaluation.
Group
Value
95% CI
Nivolumab
0.728
0.526 – 0.855
2-year Overall Survival (OS) RateSecondary· Participants were followed up to 2 years.
2-year OS rate was defined as the percentage of participants alive at 2 years.
Group
Value
95% CI
Nivolumab
100
89.4 – 100
PD-L1 Combined Positive Scores (CPS)Secondary· PD-L1 CPS assessed at baseline.
PD-L1 CPS (programmed death-1 ligand 1 combined positive score) was calculated by dividing the number of PD-L1 staining cells by the total number of viable tumor cells and then multiplying by 100. Its range of possible values was 0-100, where higher scores were better when participants received PD-L1 targeted therapy.
Group
Value
95% CI
Nivolumab
10
0 – 80
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality was assessed up to 2 years; all adverse events were collected up to 194 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab
Serious: 6/33 (18%)
Deaths: 0/33
Serious adverse events (10 terms)
Reaction
System
Nivolumab
Hyperglycemia
Metabolism and nutrition disorders
—
Atrial fibrillation
Cardiac disorders
—
Atrial flutter
Cardiac disorders
—
Chest pain - cardiac
Cardiac disorders
—
Endocrine disorders - Other, specify
Endocrine disorders
—
Hepatitis viral
Infections and infestations
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Blood bilirubin increased
Investigations
—
Cardiac troponin T increased
Investigations
—
Other adverse events (110 terms — click to expand)
Reaction
System
Nivolumab
Fatigue
General disorders
—
Hypothyroidism
Endocrine disorders
—
Oral pain
Gastrointestinal disorders
—
Hypertension
Vascular disorders
—
Skin and subcutaneous tissue disorders - Other, specify
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03692325.